Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

January 29, 2004

House Democrats Call for Revitalizing U.S. Smallpox Vaccine Program

Calling federal efforts to vaccinate U.S. health care workers against smallpox “an embarrassing failure of government, with serious implications for homeland security,” Democrats in the U.S. House of Representatives yesterday called on the Bush administration to reassess the smallpox bioterrorist threat and improve the U.S. ability to respond to such an attack (see GSN, Jan. 26).Led by Representative Jim Turner (D-Texas), the Democratic members of the House Select Committee on Homeland Security released a 19-page report yesterday lambasting U.S. efforts to prepare for the possibility of a smallpox attack.

In December 2002, President George W. Bush announced a U.S. smallpox preparedness plan that included goals of vaccinating 500,000 health care workers in a first wave and millions of workers after that. To date, fewer than 40,000 workers have volunteered to receive the vaccine (see GSN, Dec. 12, 2003).

The report identifies three “key failures” for the vaccination program’s poor performance, including poor funding of public health agencies, delayed preparation of a plan to compensate volunteers who suffered vaccine side effects (see GSN, Dec. 15, 2003), and ineffective efforts to convince health care workers that smallpox is a serious threat.

“As a result of poor management and leadership of the vaccination program, the confidence and credibility in the government from vaccinated and unvaccinated health care workers, first responders and the public is being undermined,” the report says.

The report recommends several steps to improve U.S. readiness, starting with reassessing the threat of terrorists using smallpox as a weapon.

If that threat is reaffirmed as serious, then several steps are necessary, the report says:

*include the vaccination program into a larger smallpox preparedness program and provide more help to cities and states to assess their needs and implement changes;

*renew efforts to encourage health care workers to volunteer for the vaccine by describing the nature of smallpox threat and the compensation available to volunteers who suffer side effects;

*provide adequate resources for states and localities to implement the vaccination program without affecting other public health activities; and

*integrate the smallpox preparedness program into a larger strategy to respond to bioterrorist or other health emergencies (House Select Committee on Homeland Security minority office release, January 2004)

Army won't review medication in suicides

By MARK BENJAMIN AND DAN OLMSTEDUnited Press International

WASHINGTON, Jan. 29 (UPI) -- The U.S. Army didn't investigate whether a malaria drug it developed could have triggered suicides by soldiers in Iraq, despite a new government suicide warning and complaints from soldiers, a senator and a leading veterans' advocate.

The Pentagon next week is expected to release a report on an elevated number of suicides among Army troops serving in Operation Iraqi Freedom.

Pentagon spokeswoman Martha Rudd told United Press International the Pentagon saw no reason to consider the anti-malaria drug, Lariam, as a possible factor in the suicides. Some troops in Iraq have taken the drug, particularly in the summer months. The Army said the suicide rate spiked in July.

"We don't believe there is any connection between Lariam and suicide," Rudd said. "There is nothing to indicate that is a factor."

The Food and Drug Administration last year ordered that all patients taking the drug receive a written warning that Lariam "can rarely cause serious mental problems in some patients. ... Some patients taking Lariam think about killing themselves, and there have been rare reports of suicides. It is not known whether Lariam was responsible for these suicides."

The FDA said side effects include aggression, paranoia, delusions, depression and psychosis.

"The Pentagon refuses to consider the obvious side effects Lariam produces in the combat scenario," Steve Robinson, a veterans' advocate, told a House Armed Services Committee panel last week.

"The military is ignoring this drug's known side effects," said Robinson, executive director of the National Gulf War Resource Center. "In some cases, they are lying to family members and act as if they are baffled by the high suicide and depression rates."

In October, Sen. Dianne Feinstein, D-Calif., asked Secretary of Defense Donald Rumsfeld to reconsider its use of the drug. "Given the mounting concerns about Lariam as expressed by civilians, service members and medical experts about its known serious side effects, I strongly urge you to reassess the (Defense Department's) policy on the use of Lariam," she wrote Rumsfeld.

Assistant Secretary of Defense Dr. William Winkenwerder Jr., told reporters this month that the Army was studying 19 soldier suicides in Operation Iraqi Freedom. He said that meant the suicide rate for the Army was "a little on the high side," but that "we don't see a trend there in looking at these cases that tells us there is more we might be doing to prevent suicides."

Rudd, the Pentagon spokeswoman, said the 19 suicides do not include any that occurred after soldiers left Iraq or a number of possible suicides there that are still under investigation.

UPI reported last week that since July, at least two soldiers who served in Iraq apparently killed themselves after being admitted to Walter Reed Army Medical Center in Washington, including one who hanged himself with a bedsheet Jan. 12, two days before Winkenwerder talked with reporters.

Rudd would not explain why soldiers who killed themselves outside of Iraq or Kuwait are excluded from the suicide total for Operation Iraqi Freedom, but she said there is no attempt by the Pentagon to hide suicides.

Some service members who took Lariam in Iraq told UPI that the military did not warn them of side effects noted by the FDA. Medical records for some did not reflect use of the pills, even though they still had leftover tablets.

The Army developed the once-a-week Lariam pill, known generically as mefloquine. Use in Iraq is apparently limited -- Army surgeon general spokeswoman Virginia Stephanakis told UPI, "I can tell you we are using almost no Lariam there."

The Colorado Springs (Colo.) Gazette reported that in the year ending this past October, 45,000 U.S. service members worldwide were prescribed Lariam by the military.

"I was never warned, nothing from the manufacturer in the box, nothing from the military. If I had known I would not have taken it," said one soldier who was medically evacuated from Iraq for mental problems after taking Lariam. The soldier, who asked that his name not be used, said he suffered anxiety and major depression and thought about killing himself. "I have no past history of this, never had issues with depression or anxiety and there is no family history."

He said Army doctors switched him immediately to another anti-malaria drug, but that they would not acknowledge Lariam could have triggered his symptoms. Instead, the Army is discharging him because of his mental problems.

Another soldier, Staff Sgt. Georg-Andreas Pogany, was charged with cowardice, an offense punishable by death, after he suffered a panic attack in Iraq when he saw the body of an enemy soldier. The charge was reduced to dereliction of duty and dropped altogether in December. Pogany told UPI he had taken Lariam and believes it may have triggered the attack. Panic attacks are listed under adverse reactions on the drug label.

Pogany said he received no warning about possible problems with the drug. "They gave me this medication just like I pick up my ammunition," Pogany said. "I told them that I felt like I had a nervous breakdown going on. Nobody in that company once asked or suggested that this might be a reaction to this medication."

UPI reported in early 2002 that mounting evidence suggests Lariam has triggered mental problems so severe that in a small percentage of users it has led to suicide. UPI also reported that soldiers involved in a string of murder-suicides at Fort Bragg, N.C., in the summer of 2002 after returning from Afghanistan had taken the drug.

The Army surgeon general dispatched a team to investigate. Their report said that Lariam was an "unlikely" cause for the entire cluster of deaths because not everyone suspected in the homicides had taken it. The team did not examine the drug's possible role in any individual death.

In a subsequent letter to Rep. John McHugh, R-N.Y., the Pentagon's Winkenwerder said that "the current issues regarding the adverse effects of mefloquine raised concerns within the Department of Defense as well as within the health related scientific community worldwide. In concert with other federal agencies, DOD will continue to assess these issues."

January 26, 2004

U.S. Officials Anxiously Await Passage of Bioshield Bill

By David McGlincheyGovernment Executive

WASHINGTON — U.S. public health officials said Thursday that they anticipate Congress will soon pass the Project Bioshield legislation, a sweeping bill designed to strengthen the nation’s biological defenses and also loosen restrictions on hiring biological experts and the use of emergency drugs (see GSN, July 17, 2003).

President Bush announced the Project Bioshield effort during his 2003 State of the Union speech, but the legislation has not moved with the speed that administration officials had anticipated.

“I’m hopeful that in the spring it will pass,” said Stewart Simonson, special counsel to Health and Human Services Secretary Tommy Thompson.

HHS officials are working with lawmakers to move the bill through Congress, according to Simonson, who spoke at a meeting of the Secretary’s Council on Public Health Preparedness in Washington.

Project Bioshield “seems like it’s very near,” said D.A. Henderson, the chairman of the secretary’s council and a senior scientific adviser at HHS.

House lawmakers passed the legislation last year, but it stalled in the Senate. The main resistance to the bill has come from Senator Carl Levin (D-Mich.), who is concerned that the bill will allow the White House to dole out large, no-bid contracts. Levin is reserving his right to offer an amendment to increase competition on Project Bioshield contracts, according to his spokeswoman.

“I think we are 98 percent there, but let me tell you, that last 2 percent is something,” Simonson said.

Project Bioshield includes several major initiatives, including an almost $6 billion incentive for drug companies to develop otherwise unprofitable medicines, vaccines and countermeasures to combat biological weapons. That funding has been approved by Congress and is separate from other Bioshield legislation, according to Simonson. Still being debated on Capitol Hill are portions of the plan that allow the executive branch to use unlicensed drugs in the event of a bioterrorist attack and loosen restrictions on drug procurement and hiring at the National Institutes of Health.

Federal health officials are already hiring biological experts and passage of the legislation will only speed that process, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“We’re already doing it, [the legislation] will just facilitate that,” Fauci told Government Executive. “We’re already bringing a lot of good people in.”

Fauci said that he wants to increase the amount of biological research that is developed into actual biological defenses. “We are looking for people with expertise in the transition zone between basic research and advanced development,” he said.

Simonson said that it is generally accepted that the White House would need permission to use unlicensed drugs in the case of an attack. That action would only be used “as a last resort,” he said. “We need to have the authority,” he added.

Simonson dismissed fears that the Bioshield program would be used as a cash cow for drug companies with political ties to the White House.

He said that procurement would be “very much out in the open. Nothing will be done under the radar screen.”

January 25, 2004

Ohio National Guard Member Charged For Refusing Anthrax Vaccine

Reported by: AP NewsWeb produced by: Neil Relyea

An Ohio National Guard member has been charged by the Army with disobeying a lawful order after he again refused to take the anthrax vaccine. Specialist Kurt Hickman refused to take the series of shots on January 14 after his unit was deployed to Camp Atterbury in Indiana in preparation for going overseas.

Hickman, who has said the vaccine can cause serious side effects, was formally charged on Friday as an active duty member of the Army, which places the case under the federal uniform code of military justice, according to Army Major Chris Pfaff.

Hickman could go to jail and be discharged if convicted.

Pfaff said the charge is separate from Hickman's court martial in Ohio last month.

Hickman, 20-years old, of Granville, became the first Ohio National Guard member to be court-martialed after he was convicted of disobeying a direct order in November to take the vaccination.

A military judge recommended he serve 40-days in jail, be demoted from specialist to private and receive a bad conduct discharge.

Pfaff said any penalties incurred from the latest charge could be added to those from Ohio, which are currently under review.

Hickman's previous penalty was put on hold after U.S. District Judge Emmett Sullivan ruled that the military could not force troops to take shots against their will without an order of the president.

Sullivan lifted his ban earlier this month after the FDA said the vaccine was safe and effective for use against inhaled anthrax.

More than 900,000 servicemen and women have received the shots, and hundreds of service members have been punished or discharged for refusing them, according to the Pentagon.

Legal fight puts Marine in limbo

By RON MARTZ The Atlanta Journal-Constitution ANDY SHARP / Staff

Walton High graduate Ocean Rose, 23, has gone to work for a New Jersey hazardous waste company while his bad conduct discharge is on appeal. For the last three years, Ocean Rose of Marietta has been trapped in the military version of purgatory.

In January 2001, the Walton High School graduate pleaded guilty to disobeying a superior officer. Busted to private, he was drummed out of the Marine Corps with a bad conduct discharge.

With his case on appeal since then, he technically remains a member of the Marine Corps even though he is not being paid and is not allowed to perform his duties as a firefighter and hazardous materials specialist.

Neither in nor out of the service, he finds his life and career in legal limbo.

"It's odd," Rose said recently at his parents' east Cobb home, "but maybe because it's been going on so long, it seems normal to me."

Rose, 23, is among hundreds of members of the armed forces who since 1998 have faced legal action for refusing to obey the same order: Submit to a series of anthrax inoculations.

The refusal of all of them stems from their concern about the safety and effectiveness of the shots. Yet their punishment has been far from uniform.

• Air Force Capt. John Buck, a physician from Pascagoula, Miss., stationed at Keesler Air Force Base, was convicted at court-martial in May 2001 for refusing to take the vaccine. He was denied promotion and fined $21,000 but given an honorable discharge.

• Joy Jama of Fairfax, Va., a former senior airman at Shaw Air Force Base, S.C., refused three times to take the anthrax shots. Instead of a court-martial, she was given what the military calls nonjudicial punishment, decided on by her commander. Eventually she received a general discharge under other than honorable conditions but was allowed to keep her top secret security clearance and now works for a defense contractor.

• James Muhammad of Washington, a former sergeant who wanted to make the Marine Corps his career, refused to take the anthrax vaccine last year. He pleaded guilty at a court-martial and was sent to the brig for 60 days, busted to private and given a bad conduct discharge.

• Kurt Hickman, an Ohio National Guard soldier, is facing a second military trial for refusing to take the vaccine. Found guilty in the first trial under Ohio's version of the Uniform Code of Military Justice, he was sentenced to 40 days in jail, ordered to repay a college loan from the state, and given a less-than-honorable discharge. Before Hickman went to jail, his unit was mobilized for duty in Iraq. Again he refused to take the vaccine, this time while on active duty, and a decision on another court-martial is pending.

Marines 'the worst'

Critics of the anthrax vaccine program complain that the punishments are not equitable across the services. They also say refusing to take the vaccine should not be a crime in the first place. Instead, they argue the order is illegal because the vaccine has not been proved safe or effective in humans.

"We don't know why there is such a disparity [in punishment] among the services, but the Marines seem to be the worst in the sense of being the harshest," said Mark Zaid, a Washington lawyer who has filed suit against the Pentagon on behalf of six anonymous vaccine refusers.

Pentagon officials contend the anthrax inoculations are necessary because the virus could be used by terrorists as a biological weapon. Those who resist the shots are endangering not only themselves but also others around them, these officials say.

Zaid, a defense lawyer in 10 trials involving the vaccine program, said military judges had not permitted the Pentagon's order to be challenged in any of the vaccine refuser cases. Neither have defense lawyers been able to question the safety of the vaccine or its possible harmful side effects.

"Military judges shot us down every time," Zaid said. "We never got to the merits of the argument."

Calling his defense "very limited" because of similar rulings, Rose said that "the court made it obvious anthrax [vaccine] was allowed, it was not against the law, and . . . it's safe."

Before deciding to refuse, Rose submitted to two of the shots in early 2000, shortly after arriving at Marine Corps Air Station Miramar in San Diego.

After the first shot, he experienced flulike symptoms and "a pretty good-sized lump in my arm." He had the same reaction to the second shot.

Then he went for a physical that included an electrocardiogram.

"The EKG indicated I was having a heart attack," Rose said. "I started to get worried because heart disease runs in my family. My father has had a heart attack, and my grandfather died of a heart attack."

He asked for a second test on a different machine. The results, he said, were the same.

Puzzled, Rose wondered how he could go in just a few months from being a healthy young Marine to someone with heart trouble. When Rose expressed concern that the aberrant heartbeat might have resulted from the anthrax shots, a Navy doctor replied that they were safer than flu shots.

"This wasn't adding up," said Rose, who began doing research on the vaccine. "I found things the military doesn't want you to know" about possible adverse effects and health risks for those who take the vaccine.

Critics of the vaccine have questioned the adequacy of its testing and expressed concern about possible links to cancer and birth defects.

The military insists the vaccine is safe. "Our position is the same position as the [Food and Drug Administration]: The vaccine is safe and effective," said Jim Turner, a Pentagon spokesman.

But the FDA did not make that ruling until last month.

For the previous 18 years, Zaid said, the vaccine had been considered an investigational drug, that is, one that is under study but is not yet permitted to be legally marketed and sold in the United States.

Injunction halted

The FDA's finding came in the midst of Zaid's suit against the government and just a week after a U.S. District Court judge in the District of Columbia issued an injunction stopping the Pentagon from ordering further anthrax inoculations because of his concerns about their safety.

Despite his misgivings about the timing of the FDA's ruling, Judge Emmet Sullivan lifted the injunction and the shots resumed.

Over the last three years, Zaid said, many vaccine refusers have been given nonjudicial punishment and a general discharge rather than court-martial.

The services differ on the quality of statistics they keep regarding vaccine refusers, despite a law requiring them to submit detailed annual reports to Congress.

Spokeswoman Valerie Burkes said 85 vaccine refusers in the Air Force had legal action taken against them since 2000. Only three were court-martialed.

Army spokeswoman Martha Rudd said the Army did not specifically track cases of vaccine refusers.

"We are aware of a few cases in the last several years, but the number is small," she said in an e-mail response to questions.

Burkes, also responding by e-mail, said no policy determined how commanders should deal with anthrax refusal cases or what punishment should be given.

"Each commander exercises his or her own best judgment, after reviewing all the facts, in determining how to appropriately handle a case in the best interests of justice," Burkes wrote.

The Navy judge advocate general's office, which handles Navy and Marine Corps cases, said it also did not track vaccine refuser cases.

Carolyn Alison, an office spokeswoman, said "fewer than 10" anthrax refusal cases were pending before the Navy-Marine Corps Court of Criminal Appeals, Rose's among them.

Rose decision perplexing

Rose's case has twice gone before the Naval Clemency and Parole Board, which reviews discharges for possible upgrading.

The first time, a recommendation that Rose be reinstated to active duty was denied. The second time, a recommendation that his discharge be upgraded also was denied, said Geoff Lyon, a Washington lawyer and retired Marine lieutenant colonel who was on the board.

Of 16 cases considered for upgrading when he was the board's president, Lyon said 12, including Rose's, were sent to the Department of the Navy with a recommendation for upgrade.

"His package was stronger than the other 12 we upgraded," said Lyon. But the upgrade was denied without explanation.

Rose is permitted to wear his uniform but chooses not to. He does not want to strip off the treasured lance corporal stripes he earned during the two years he served.

Rose has no discharge papers, since legally he is still a Marine. Without a discharge, many prospective employers are reluctant to hire him because he could be called back to active duty at any time.

If his bad conduct discharge is not overturned or upgraded, he will be unable to get a government job or be eligible for veterans benefits.

Until about six months ago, Rose made do with a series of low-paying jobs. He now works as a hazardous materials specialist for a New Jersey company.

Rose's lone hope is for the appeals court to side with him. But that could take years. Some appellate cases are more than 5 years old.

He said he has no regrets and still loves the Marine Corps.

"I'm comfortable with the decision I made," he said. "But I thought the punishment seemed severe. I was being compared to someone who disobeyed an order to protect my country, but all I did was refuse to take a shot."

January 23, 2004

Study slams biodefense plan

By Robert Schlesinger, Globe Staff, 1/23/2004

WASHINGTON -- The Pentagon's efforts at creating new vaccines and drugs to combat biological weapons are poorly organized, underfunded, and unlikely to produce successful results in the near term, if ever, according to a congressionally mandated study released yesterday.

According to the report, the United States has not developed any vaccines and "only a few drugs as medical biodefense countermeasures" since the 1991 Persian Gulf War, when the specter of biological warfare against US troops was first brought to the public consciousness.The study, by the Institute of Medicine and the National Research Council, recommended that Congress establish a new Medical Biodefense Agency to direct Defense Department research and development of medicines for dealing with biological warfare attacks as well as regular infectious diseases.

"The biodefense efforts of the Department of Defense are poorly organized to develop and license vaccines, therapeutic drugs, and antitoxins to protect members of the armed forces against biological warfare agents," said the report's executive summary. "These efforts are characterized by fragmentation of responsibility and authority, changing strategies that have resulted in lost time and expertise, and a lack of financial commitment commensurate with the requirements of program goals."

The study was commissioned by Congress to look at the Defense Department's research into medical defenses against biological warfare, such as vaccines and other drugs.

"The Department of Defense is evaluating the recommendations of the . . . report. We generally agree with many of them," said a Pentagon statement from Defense officials. "We are committed to doing what is required to ensure protection of the health and well-being of our troops."

President Bush has identified biological weapons as one of the gravest threats facing the United States. He based his call for war in Iraq partly on the allegation -- still unproven -- that the country had vast stores of biological weapons. One of the greatest areas of concern for US military commanders and political leaders in the run-up to the invasion of Iraq last year was the prospect that the Iraqis might unleash biological attacks against advancing allied forces. President Bush ordered US forces to be immunized against anthrax and smallpox.

Indeed, according to the report, there have been no less than a half-dozen declarations since 1993 from either the White House or the Pentagon "that biological warfare poses a significant threat to the safety and effectiveness of the nation's armed forces." Congress mandated in 1993 that all of the Pentagon's biological and chemical defense activities be coordinated in a single office under the defense secretary's office.

Nevertheless, funding for new vaccines and drugs to combat biological attack has fallen short, the report found. While funding for Pentagon medical biological defense research has increased from $245 million in fiscal year 1996 to $676 million -- including funds spent by the Defense Advanced Research Projects Agency -- in fiscal year 2003, the figure remains small, according to the study. By comparison, funding for the Missile Defense Agency, "which has a different but also difficult research and development task with a high risk of failure," has risen from $2.8 billion in fiscal year 1996 to $6.6 billion in fiscal year 2003. The Bush administration budget request for fiscal year 2004 contained a cut in medical research for biological defense, down to $612 billion, along with a nearly billion-dollar increase for missile defense.

Since the Sept. 11, 2001, terrorist attacks, the Bush administration has stepped up civilian research into medical defenses against biological agents, most notably with a $1.7 billion grant in fiscal year 2003 for research at the National Institutes of Health, though the administration's fiscal year 2004 request was $1.6 billion. The administration has also proposed Project BioShield, which aims to create $6 billion in incentives over 10 years for the pharmaceutical industry to produce medical countermeasures.

January 21, 2004

FDA fails to halt anthrax anxiety

Insight MazagineBy Timothy W. Maier

For thousands of Gulf War veterans the holiday season was a roller-coaster ride. Many celebrated when a federal judge ruled in late December the anthrax vaccine was experimental if used to protect against inhaled anthrax instead of anthrax poisoning by skin contact. The ruling immediately put a halt to the military's anthrax-vaccination program in which more than 1 million troops already have been inoculated since 1998. But eight days later, on Dec. 30, the U.S. Food and Drug Administration dropped a bombshell that in effect reversed the court ruling by declaring the anthrax shot was safe and effective against anthrax delivered by aerosol spray. The adverse-reaction rate of the anthrax vaccine is anywhere from 5 percent to 35 percent.

In 1972, the FDA gained jurisdiction over vaccines and related products from the National Institutes of Health. In 1985 the FDA proposed the anthrax vaccine and some others as safe and effective against bacterial infections but never completely certified those conclusions.

The recent finding, eight days after the court ruling on anthrax vaccination of U.S. troops, was said to be part of a process to certify proposals and findings since the FDA took jurisdiction more than 30 years ago. The official explanation for the timing is that the anthrax attacks of 2001 pushed the FDA to finish the job and issue a final rule based on a review by an expert panel. In any case, the FDA released its final ruling with a prepared statement that clearly indicated a bureaucratic reaction to the decision of the federal court.

"A recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as 'investigational' with regard to protecting against inhalation anthrax," the FDA stated. "Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax." So that no one missed the point, the FDA also declared this ruling should be noted in any further litigation.

"This will end all lawsuits," claims D. Jacques Smith, an attorney for Michigan-based BioPort Corp., the sole supplier of the anthrax vaccine. "We always believed that the vaccine had a very low risk. The risks are equal to the flu vaccine that I received last month." Except for one slight detail: Coroners do not cite the flu vaccine itself as the cause of death, while the anthrax and smallpox vaccines given to U.S. military troops have been listed as the cause of death for at least a half-dozen veterans, according to civilian medical examiners. Pentagon doctors in turn dispute those conclusions.

The immediate approval of the anthrax vaccine set off a firestorm of criticism among veterans who believe they are being subjected to unnecessary risk. One veteran put it this way: "The ruling is decades overdue and rife with problems, including relying on animal data to fill the legal void created due to the lack of valid human data. A full vetting of the facts is required in order to hold Department of Defense and FDA officials accountable for their abuses of power and discretion."

That full vetting is not likely to happen.

Congress disappeared from the debate shortly after Capitol Hill offices were struck by the anthrax mailings in 2001, and it now appears unlikely that there will be hearings about these problems, especially in light of the recent FDA final ruling. Immediately seizing on the FDA's decision, the Justice Department requested U.S. District Judge Emmet G. Sullivan set aside his preliminary ban and proceed with the class-action lawsuit against the Pentagon by six "John Doe" plaintiffs seeking to stop the vaccination program.

Sullivan, who had ruled that U.S. soldiers should not be used as "guinea pigs" for experimental drugs, since has backpedaled in light of the FDA's finding. While his ban was in line with findings of experimentation by congressional reports from both the House and Senate, the FDA's ruling left him no choice. He lifted the ban Jan. 7, but not before he called the FDA ruling "highly suspicious," following as it did so closely upon the heels of his injunction. "Only after the issuance of an injunction, up pops a federal rule," Sullivan declared with acid sarcasm to Justice Department attorney Shannen Coffin, who is representing the Pentagon in the lawsuit filed by the six John Does. "And you're telling me it's coincidental?" "I'd stand on a stack of Bibles and tell you it's coincidental," Coffin replied to Sullivan. "That's an amazing coincidence," Sullivan shot back.

The FDA claims its final ruling was made prior to Sullivan's holding even though it was not made public until after the ban was implemented. Nonetheless, Sullivan's ban prevented several thousand troops from receiving the inoculation before being sent out to high-risk areas to fight the war on terrorism. Coffin argued that every day the injunction was in place meant that 1,000 additional troops could face harm for being unprotected from anthrax.

Sullivan's ban also prompted an angry response from Assistant Secretary of Defense William Winkenwerder, who called it bad medicine. "It challenges the conclusions of America's best medical experts," he told reporters at his weekly briefing in late December.

Winkenwerder stressed "paramount concern" for the safety of the troops and noted from the evidence of anthrax attacks in the United States that "it doesn't take a Scud missile to kill with anthrax. All it takes is an envelope."

Indeed, said Winkenwerder, "The safety and the effectiveness of the anthrax-immunization program is based upon the best science in the world. In March 2002, the National Academy of Sciences' Institute of Medicine concluded in an exhaustive 250-page report – right here – that the anthrax vaccine is, and I quote from this report, 'an effective vaccine for the protection of humans against anthrax, including inhalation anthrax, caused by all known or plausible engineered strains of bacillus anthracis' – that's the medical term for anthrax. The department fully supports this scientific finding and those of the FDA that the anthrax vaccine is safe and effective against all forms of anthrax." Critics shrugged that FDA bureaucrats had been brought in to rescue the military, to offset claims that U.S. troops were being used as guinea pigs.

While the Pentagon appears to have won the first round, Mark Zaid, who is representing the six anonymous plaintiffs, says he is not about to quit. The scrappy attorney says the ruling "is nothing more than after-the-fact gamesmanship to overrule the court's findings. It appears to be reflective of policy duress rather than independent analysis."

The central issue is whether the anthrax vaccine is licensed for inhalation anthrax, Zaid says. In hindsight, the plaintiff attorney says the Pentagon might have avoided the entire controversy by claiming that the vaccine was to protect troops in case they came into contact with anthrax through the skin, because no one disputes it was licensed for that situation. "If they had taken that posture from day one they could have gotten away with it," Zaid says, although he believes there are legitimate health-risk issues even in that case which have not been fully addressed.

Zaid now plans to argue against the FDA's ruling that the vaccine is safe and will challenge the manner in which the Pentagon may have violated the process by giving the vaccines to some troops out of sequence. The FDA requires that a six-shot regime must be followed in a specific order and completed in a specific time frame for the vaccine to work effectively.

Since 9-11 there no longer are hundreds of veterans publicly speaking out against the vaccine, but there remain pockets of resistance, primarily among reservists who believe adverse reactions to the vaccine may affect their civilian employment. These critics point to Sept. 20, 1996, when the manufacturer submitted a request for an investigational new drug application, IND 6847, to the FDA for new labeling of the vaccine, which would indicate use for inhalation anthrax.

Shortly afterward on Oct. 15, 1996, the Army placed an ad in the Washington Post to recruit subjects for experimental research related to the manufacturer's requested IND. An angry FDA fired back a letter to the chairman of the Army's Human Use Committee at Fort Detrick, Md., objecting to the request and advertisement. Reservists believe the Pentagon's decision to try to change the labeling in 1996 proved one thing.

"The DoD knew its use of the anthrax vaccine was experimental," charges a reservist who asked not to be identified. "The FDA also knew. Both agencies are circling the wagons, protecting themselves, rather than correcting the wrongs inflicted on thousands of soldiers. The dilemma is an ethics case study of failures to self-regulate and act in the best interests of our citizens and soldiers."

While the manufacturer never got its new label, BioPort now can, says FDA spokeswoman Lenore Gelb. However, she says, that may not be necessary because the previous label says the vaccine protects regardless of the route of anthrax exposure. The FDA approved the vaccine in 1970 both for inhalation anthrax and skin contact, she insists. The FDA's position is that the vaccine was never investigational, except when it was used on postal workers.

Gelb explains the vaccine is considered investigational with postal employees because it was used only after they were exposed to anthrax. She also claims that neither the Pentagon nor the White House applied pressure on the FDA to issue its final ruling after the judge dropped the hammer on the Pentagon for using experimental drugs on U.S. troops. "It's something that has been in the process for some time," she says. Critics, meanwhile, point to a jump in adverse reactions to the vaccine that increased from 0.2 percent to somewhere between 5 percent and 35 percent. Col. John Grabenstein, deputy director of the anthrax-immunization program, downplayed those statistics, claiming most of these reactions reflect a change in collection method. The reactions are minor, he says, ranging from headaches to swelling at the injection site.

"If you asked – if you went looking for the side-effect data on flu shots, you'd be getting something in the range of 5 to 35 percent. These are not scary numbers," he insists.

"Tell it to Rachael Lacy!" says a member of the armed forces who asked not to be identified for fear of retaliation. She is the U.S. Army sergeant who died last year because of complications from the vaccine, according to an autopsy report from the Mayo Clinic in Rochester, Minn. Six others also died mysteriously after rolling up their sleeves to receive the anthrax and smallpox shots. But the Pentagon and the FDA dismissed these and related claims, declaring that the vaccine has a 92 percent rate of effectiveness.

Even so, some studies suggest the vaccine does not work against all strains. And while the Pentagon has remained steadfast in its claim of safety, it quietly has told veterans to be careful what they say about the vaccine. The fear of such intimidation has many worried veterans telling Insight that they no longer report what they believe to be vaccine-related illnesses. What also may become alarming is a wave of pneumonia cases that some believe are related to the shots. Already, at least 17 have died as a result of complications from pneumonia.

The recent FDA finding also appears to be a direct shot at the ongoing lawsuit filed by six John Does who argue that the anthrax vaccination was an illegal experiment because, they claim, it was investigational for inhaled anthrax and therefore banned.

In 1991, after many Gulf War I veterans returned home with mysterious illnesses, Congress passed legislation forbidding the Pentagon from using troops as guinea pigs. If the anthrax vaccine was the cause of Gulf War Syndrome it certainly would not be the first time the military served up troops for experiments. The government failed to warn troops in World War II about the potential long-term dangers of mustard gas, and the same was true of atomic radiation during the Cold War and Agent Orange in Vietnam. This experience, combined with the latest outbreak of pneumonia that appears to be related to the anthrax vaccine, has created uneasiness among military personnel.

About 500 active-duty troops have refused to take the vaccine after a series of reports on deaths and illnesses came to light. The Pentagon has court-martialed about 200 of these troops. In addition another 500 pilots and flight-crew members have quit or transferred from the Air National Guard or Reserves, according to plaintiffs' lawyers, troops and base sources.

But Winkenwerder insists the storm has passed. Since 9-11, he boasts, only 10 troops have refused the vaccinations, while 600,000 to 700,000 rolled up their sleeves and did as they were told. "So, contrary to what I think has already appeared in the press about several hundred service members refusing, that was prior to Sept. 11, in the period of 1998 and 1999," Winkenwerder says. "Our experience the last two years is that our service members support the vaccine program and accept it."

Not everyone is accepting Winkenwerder's view.

"The [Department of Defense's]conscious mandate of anthrax vaccine for an unapproved use is just the tip of the proverbial iceberg, an ethical dilemma looming beneath the surface," charges a high-ranking veteran. "Illegal manufacturing changes before the first Gulf War increased the potency up to a hundredfold, adulterating the vaccine. DoD failed to study the vaccine in general or the illegal changes made to the vaccine as a possible cause of Gulf War illness." The FDA does admit it is continuing to study long-term health risks associated with the anthrax shot. The results of that study have yet to be completed.

This alone makes some wonder why the study was not completed prior to troops being subjected to the vaccine. They will have to wait to find out if there are long-term problems. But by then, some worry, it might be too late.

January 15, 2004

A COLONEL has become the first Ministry of Defence doctor to blame Gulf War Syndrome on vaccinations given to soldiers.

Lieutenant Colonel Graham Howe's comments are a boost to a compensation claim by a sick Scots former sapper.

Howe examined Alex Izett for the War Pensions Agency.

Izett, a former lance corporal in the Royal Engineers, says his severe depression and brittle bone disease were caused by the cocktail of drugs a claim echoed by other veterans.

And, in his report, Howe wrote: ''It seems most certain that Mr Izett did in fact receive classified secret injections prior to his expected deployment.

''These have most probably led to the development of autoimmune induced osteoporosis, which has clearly been a major participating factor in the development of his recurrent depressive illness." Last year, Izett won a ruling from the War Appeals Tribunal linking the symptoms to the injections.

Izett, originall y from Cumbernauld, near Glasgow, released his medical records yesterday to raise awareness of the problem.

At home in Germany, Izett who was given the injections but never went to Iraq said: ''I want to help people who have suffered like me.''

A spokeswoman for the MoD said: ''We've accepted that some who served in the 1991 Gulf conflict became ill. But Gulf War Syndrome is not a recognised disease.''

January 13, 2004

Hackworth: Politicians – Read This Before Self-Destructing

By Retired COL David Hackworth

January 13, 2004

The recycled Pentagon types now merrily selling their “expertise” to the weapon-makers and the rest of the current crop of shakers and takers who make up today’s military-industrial-congressional greed machine are as usual sucking up big bucks, while many of our vets continue to get the shaft. Also as usual.

Wesley Clark summed up what’s going down in a recent campaign speech: “We've got veterans hospitals closing; we’ve got people who have to drive six hours to get a checkup; we’ve got veterans that are waiting six months to get an appointment ... that’s not health care."

If elected, Clark promises to add $2 billion to the vet health-care budget. “We’ve got to fix the veterans’ issues here in America,” he said. “We're going to put the full funding we need to get the Veterans Affairs to meet our ... former service members’ needs.”

Since 1996, the VA’s workload has increased from 3 million to 7 million vets without a comparable increase in operating funds. There’s presently neither the money nor the infrastructure to take care of all those who paid the hard price when Uncle Sam said, “I want you.” Which is why the enrollment of thousands of eligible vets in the category designated as Priority Group 8 – non-service disabled vets and those with incomes higher than $24,000 a year – were dropped like a live grenade last year.

According to VA honcho Anthony Principi, this suspension affects only the lowest priority group in the VA’s eight-tier system – vets in Group 8. But he says Priority 8s already enrolled will be “grandfathered” and allowed to continue in the VA health-care system.

“Who is Principi to play God?” asks Vietnam vet Lawrence Tahler. “When is a vet not a vet, and why should these good men and women be penalized for not getting their paperwork in before some bureaucrat arbitrarily decides to change the system?”

“I'm a Priority 8 Vietnam vet who was denied enrollment,” Donald Schlotz says. “As a result, I annually spend over $7,000 on health insurance for promised care that would otherwise be provided by the VA. It looks to me like the Bush administration is trying to save money at the expense of vets who were assured they’d have health care for life.”

Millions of vets who agree with Schlotz are angry because they believe the Bush administration has looked the other way when it comes to the aging veteran population.

But Bush’s $63.6 billion 2004 VA budget actually comes in at a whopping 7.7 percent increase over last year's allocation – the biggest VA increase in history. The bummer is, that’s far from enough dough to do the job.

“This action against Priority 8 vets is outrageous,” Schlotz says. “It's particularly distasteful that this now pits vets against each other for benefits, rather than providing benefits for all. Moreover, by ‘grandfathering’ some vets, it discriminates between similarly situated vets based on nothing other than when they applied for benefits.”

The Priority 8s are the victims of a government that’s forgotten George Washington’s sage warning, “The willingness with which our young people are likely to serve in any war, no matter how justified, shall be directly proportional to how they perceive the veterans of earlier wars were treated and appreciated by their nation.”

While Clark has low-balled the money needed to get the VA program back on track, he's spot on when it comes to the 2004 election. Veterans – and there are millions of them from sea to shining sea – have vowed to hold our politicians’ feet to the fire this time around to make sure they honor our nation's sacred obligation to the men and women whose sacrifices have made our country the freest in the world.

Principi recently said, “Our veterans deserve nothing less than the best a grateful nation has to offer.”

Sounds good. But Principi, the president and Congress should be told that America’s vets need action, not more glowing words. Payback begins at home. Our country’s service heroes must be properly looked after before the rest of the world gets any more goodies. And certainly before the powers that be give another thought to colonizing the moon or Mars.

January 12, 2004

Report: Gulf War Syndrome linked to vaccines

CNN - TV USA

LONDON, England (Reuters) -- A leaked British Army medical report has provided the first official backing that vaccines given to British soldiers before the 1991 Gulf War caused illnesses associated with Gulf War Syndrome, the Times reported on Monday.

It said Lieutenant-Colonel Graham Howe, clinical director of psychiatry with the British Forces Health Service in Germany, made the link after the War Pensions Agency asked him to look at the case of former Lance-Corporal Alex Izett, who now suffers from osteoporosis and acute depression, the paper said.

The Times quoted Howe as saying in his unpublished report, dated September 2001 and handed to the paper by Izett, that "secret" injections given to the soldier "most probably led to the development of autoimmune-induced osteoporosis."

Howe came to that conclusion because in the end Izett was never posted toIraq, the Times said.

The paper added that Izett won a landmark ruling at a war pensions appeals tribunal last summer which awarded him a 50 percent disability pension.

The existence of Gulf War Syndrome and its possible causes have been hotly debated.

It has been linked variously to the inoculations the veterans received, pesticides they handled, smoke from oil-burning fires, stress and organophosphates -- chemicals that have been shown to affect the human nervous system.

U.S. and British veterans of the conflict have complained of symptoms such as respiratory and digestive problems, nerve damage, fatigue, pain, numbness and memory and psychological problems.

January 8, 2004

Judge Decides Pentagon Can Resume Anthrax Vaccinations

By Vernon Loeb Washington Post Staff Writer Pentagon May Resume Vaccinating Members of Military

A federal judge in Washington lifted a preliminary injunction yesterday and told the Pentagon that it may resume a program of mandatory anthrax inoculations for all U.S. service members except six plaintiffs in a lawsuit challenging the legality of the government's anthrax vaccine.

U.S. District Judge Emmet G. Sullivan ruled after the Food and Drug Administration issued a formal determination last week that the vaccine provides effective protection against deadly anthrax bacteria, whether they are inhaled or absorbed through the skin.

In issuing his injunction on Dec. 22 blocking mandatory anthrax inoculations, Sullivan ruled that the vaccine is an experimental drug "being used for an unapproved purpose" because the FDA has formally authorized its effectiveness only against anthrax spores absorbed through the skin.

With a court date in the case set for next week, neither the Justice Department nor the Pentagon had any immediate comment on Sullivan's latest ruling or the status of the vaccine program, which the Defense Department suspended pending further action by Sullivan.

Mark S. Zaid, a Washington lawyer who filed the suit challenging the program, called Sullivan's decision lifting the preliminary injunction a temporary setback and said his clients would prevail at trial in challenging the anthrax vaccine.

Zaid said he will soon ask Sullivan to reissue an order blocking mandatory anthrax inoculations because the FDA's approval of the vaccine was itself flawed, based only on animal research. Another government investigation of the vaccine, being carried out by the Centers for Disease Control and Prevention and based on human research, will not be completed until 2007, he said.

Zaid said he will also soon introduce evidence in court to bolster his argument that, even with the new FDA approval, the anthrax vaccine should still be considered illegal because it is being improperly administered by the military.

While the FDA maintains that the vaccine is safe and effective if service members receive a total of six injections over an 18-month period, the military does not follow the proper injection schedule and often administers two or three shots, instead of the required six, Zaid said.

In defending the program and asking Sullivan to lift his preliminary injunction, senior defense officials said the anthrax vaccine is safe and effective for military personnel. Before the FDA's determination last week, they cited a March 2002 study by the National Academy of Sciences' Institute of Medicine concluding that the vaccine is effective "for the protection of humans against anthrax, including inhalation anthrax, caused by all known or plausible engineered strains of Bacillus anthracis."

At the time, defense officials bristled at Sullivan's conclusion that service members receiving the anthrax vaccine were serving as "guinea pigs for experimental drugs."

A million service members have received the vaccine since the Pentagon began a program for mandatory inoculations in 1998, including 600,000 to 700,000 who received the vaccine since June 2002 as the military prepared for war in Iraq. Hundreds of other service members have refused to take the vaccine out of concerns about its safety, and many have been court-martialed for refusing the vaccine, forced out of the military and, in some cases, imprisoned.

January 5, 2004

Some await anthrax shot antidote

ERIC STEINKOPFFDAILY NEWS STAFF

James Muhammad says that those who check his record will see he was a good Marine. An honor graduate from several military courses, he also received at least one meritorious promotion. In only two years and 11 months, he was promoted to sergeant on Nov. 1, 2002 - a rapid rise through the chain of command.

On Nov. 29 of that same year, Muhammad, a data networking specialist assigned to 8th Communications Battalion at Camp Lejeune, received the Good Conduct Medal.

But in a few days everything changed. It happened after he expressed concerns about the anthrax vaccine.

"When I came into the Marines the only thing I wasn't going to give up was my religious convictions - anything else was negotiable," Muhammad, a Muslim, said Friday. "I was ordered one time and there was no discussion about it. I was told that we were taking the anthrax shots the next day and it made me feel weird. I told my staff sergeant that I had some concerns about it."

Muhammad refused to take the vaccine. Less than six months later, on April 9, 2003, he was sentenced to 60 days in the brig, demoted to the rank of private and received a bad conduct discharge. He was jailed, strip-searched and housed with violent criminals.

"It's very odd showing up at the brig as a sergeant," Muhammad said. "A lance corporal started yelling at me like a drill instructor. When you first get there they don't know why you're there - they just think that you're the scum of the earth. The worst part was visiting on Saturday and Sunday - to have my wife see me like that."

Now Muhammad wonders what will happen next. In December, a U.S. District Court Judge in Washington ordered the military to stop giving troops anthrax vaccinations unless they volunteer or if a presidential order is given.

"The women and men of this country put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy," Judge Emmet G. Sullivan said in his ruling. "Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."

Muhammad and other servicemembers skeptical about the vaccinations applauded the ruling but were not optimistic about how their cases might be resolved. Muhammad is considering hiring a lawyer. Some members of Congress are calling for reparations for those who were punished and Muhammad said correcting his military record and reinstating him to the rank of sergeant are a start.

"I'm not letting this go," Muhammad said.

Paying the price

Muhammad is one of at least two Lejeune Marines who refused to receive anthrax vaccinations and faced punishments in military court. 1st Lt. Erick Enz, a CH-46 Sea Knight pilot with Marine Medium Helicopter Squadron 162, Marine Aircraft Group 29 at New River Air Station, pleaded guilty and was dismissed from the Marine Corps.

Muhammad claims that those who were in a position to help him follow his religious beliefs were actually gathering information to use against him.

"I hadn't even been given an order yet and they started the ball rolling," Muhammad said. "As soon as I said that I had concerns, they contacted legal to find out what they needed to do to charge me."

Muhammad said each person who talked with him took notes and made statements to testify in the case against him.

"I thought that they were trying to help me, but they were making sure that they could file charges on me," Muhammad said. 'They said that I could not have an attorney until formal charges are filed. I questioned the legality of the order in writing."

Muhammad also said his young military defense lawyer wasn't up to the challenge of a complicated case.

"I was given military counsel, but my recommendation is regardless of the charges, get civilian counsel."

Enz paid a high price, too, Muhammad said.

"I sat at the Erick Enz trial in pain," Muhammad said. "I learned later that he should never have pleaded guilty and I shouldn't have pleaded guilty. That's the thing that bothers me most.

"I learned later that you have to do something with the intent to break the law or for personal gain to be guilty," Muhammad said.

Dangerous, or not

Department of Defense officials contend that the vaccination is safe, as do military doctors at Camp Lejeune Naval Hospital. But a September 2002 U.S. General Accounting Office report to Congress says that the rate of severity of adverse reactions to the vaccine are considerably greater than advertised.

Two Marines, one from Camp Lejeune and another from New River, contend that anthrax vaccinations they received in the Marine Corps gave them symptoms similar to Gulf War Syndrome. Neither served in Kuwait or Iraq. Both were recently given medical discharges.

Sgt. Brian Fleming, 29, an infantryman formerly with Weapons Company, 2nd Battalion, 6th Marine Regiment, served for eight years in the Marine Corps but watched as his body began to fall apart.

"I had four anthrax shots and started having problems," Fleming said. "We were sitting off the coast of Sierra Leone and I started having extreme joint pain. I (also) had digestive problems, my skin broke out in hives from head to toe, there is ringing in my ears, memory loss and migraines."

Fleming originally thought that he might have hurt himself working out. He was hesitant to seek medical attention.

"I was a career minded infantry Marine," Fleming said. "When my shoulder started going it was like a rotator cup injury, (so) I went to the corpsman outside of the (Battalion Aid Station) - a sergeant doesn't go to sick call."

But the pain and complications got worse. It got a point that he could not longer serve.

"But I wasn't going to make a big fuss because I've seen what happens to others," Fleming said. "The ones who refuse get kicked out with a dishonorable discharge. For people with bad symptoms who said it was anthrax - it was like raising a red flag because everyone in their chain of command came down on them. As much as I love the Marine Corps, I'd have refused the shot and taken the stinking dishonorable discharge if I knew then what I know now."

"I think it's a wonderful thing that they suspended (the shots) - it affected me deeply," Hawkins said. "Maybe that will save some men and women some grief. I had to go to a civilian doctor to get things done - the actual diagnosis."

Hawkins looks at the anthrax shots with regret, but is resigned to his fate. He likes the idea of helping others who are less fortunate.

"I wish that I never took it, but I'm glad that I'm helping others out who are having a hard time dealing with it," Hawkins said. "I'm a proud American and I would serve my country again. I'm a Marine - trained to survive and that's really all I can do right now. There are guys out there without family, so when this happens to them, who do they have to turn to?"

Although he suffered through about 18 months of medical treatments, hospitalization and convalescent leave, Hawkins praised his unit for understanding.

"They put you on medication so you can't drive yourself to work and you spend a lot of time in the hospital," Hawkins said. "A lot of guys still had to come in to work."

What next?

Opponents of the anthrax vaccination program seemed to have won a victory with Sullivan's ruling. Lacking approval by the Food and Drug Administration, Sullivan found that the anthrax vaccination is "an investigational drug and a drug used for an unapproved purpose."

"I've given up on the military making a diagnosis," Fleming said. "They're all worried about their careers. They can't come right out and say that somebody poisoned us. It's politics, something way above us at the Department of Defense executive branch level."

Muhammad agrees.

"These guys play hard ball," Muhammad said. "There will probably be a conference room deal, a handshake and it will all end up in the Supreme Court."

Coincidently, the FDA Tuesday approved the safety and effectiveness of the vaccine after an 18-year delay.

"The data in the final rule is the same (that we've had) for the last six years of controversy," said Washington, lawyer Mark S. Zaid. "We filed in March, argued in May and (up to now) nobody would even allow us to hear the merits of the case. The timing of the FDA ruling, one week after judge Sullivan's ruling is extremely suspicious."

Sullivan's ruling gives the military until Jan. 30, 2004 to file its response to the injunction. Lawyers for the Department of Defense are to meet with the court by Feb. 24, file final arguments by March 2 and meet again in a conference session on or about March 9.

In a Dec. 23 press release, the Department of Defense said it "will stop giving anthrax vaccinations until the legal situation is clarified," while still maintaining that the "vaccine is safe and effective for all forms of anthrax exposure."